MARK3 - Bite Registration Regular Set 2/bx. - MARK3 EU - CARGUS INTERNATIONAL, INC

Duns Number:096191093

Device Description: Bite Registration Regular Set 2/bx. - MARK3 EU

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More Product Details

Catalog Number

-

Brand Name

MARK3

Version/Model Number

1170

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

58f31bf2-ecf6-4d1b-9150-2474fad82d13

Public Version Date

June 18, 2018

Public Version Number

1

DI Record Publish Date

May 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARGUS INTERNATIONAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 96
2 A medical device with a moderate to high risk that requires special controls. 93
U Unclassified 1